This book outlines planning and implementation of a Good Manufacturing Processes (GMP) analytical program, structured to build an environment and culture that encourages and rewards the sharing of ideas, skills and abilities among department personnel.
Essential Elements for a GMP Analytical Chemistry Department is a systematic approach to understanding the essential elements required for a successful GMP Analytical Department to function as an efficient and effective organization. It describes in detail a department structure which allows for the necessary processes to become available to all its personnel in a way where there is a free flow of information and interaction. The environment and culture created by this approach encourages and rewards the sharing of ideas, skills, and abilities among department personnel. The essential elements such as , SOP's, regulatory guidance's/guidelines, project teams, technical and department processes, personnel motivation, outsourcing, and hiring the best is among the many topics that are discussed in detail and how they can be implemented to build an efficient and effective Analytical Department. This book will serve as a valuable asset to the many companies required to perform GMP analytical method development, validation, analyses etc including start-up, virtual, and generic pharmaceutical companies. _
Introduction.- Organization.- Department Structure.- Project Teams.- Responsibilities.- Interactions.- Operating Guidance's.- Processes.- Safety.- Technology.- Department.- Statistical Concepts for the Analytical Chemist.- Data distribution.- Significance Testing.- Confidence Intervals.- Outliers in analytical data.- Regression.- Experimental design.- Required sample replicates.- Method performance.- Uncertainty measurement.- Sampling strategies.- Outsourcing.- Process.- Audit Check List.- Documentation.- Sample Submission.- Technical Report.- Reports of analysis.- Records (Training etc.).- Job Descriptions.- Career Tracks.- Motivating Personnel.- Career Path.- Hiring the Best.
Describes a systematic approach to establishing an effective GMP analytical department
Discusses the development and management of project teams
Describes an outsourcing process to ensure all activities are properly addressed and none are overlooked¿